Trial · NCT00345345
Alemtuzumab (Campath) to Treat T-Large Granular Lymphocyte Leukemia
NCT00345345, Phase 2, Completed, National Heart, Lung, and Blood Institute (NHLBI); results first posted 2019-05-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Alemtuzumab (Campath) to Treat T-Large Granular Lymphocyte Leukemia. Trials, record NCT00345345. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00345345
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Alemtuzumab (Campath) to Treat T-Large Granular Lymphocyte Leukemia
- NCT number
- NCT00345345
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 29 participants, actual
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)
- Conditions
- T-LGL Lymphoproliferative Disorders
- Interventions
- Alemtuzumab (Campath)
- First posted
- 2006-06-28
- Last updated
- 2022-05-03
- Results first posted
- 2019-05-03
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Hematological Response After Three Months of Alemtuzumab | 3 months | The primary endpoint was hematologic response at three months after treatment. A complete response (CR) was defined as normalization of all affected lineages, and a partial response (PR) was defined in neutropenic subjects as 100% increase in the ANC to \>500/µL, and in those with anemia, any increase in hemoglobin of 2 g/dL or more observed in at least two serial measurements 1 week apart and sustained for one month or more without exogenous growth factors support or transfusions. |
| Secondary | Number of Participants That Are Red Blood Cell and/or Platelet Transfusion-Independent | 3 months | Number of participants that are red blood cell and/or platelet Transfusion-Independent following Alemtuzumab |
| Secondary | Participants Overall Survival After Alemtuzumab Infusion | 3 months | Participants overall survival after Alemtuzumab infusion for cell large granular lymphocytic leukemia (T-LGL) at month 3. |
| Secondary | Number of Participants That Experienced a Life-Threatening Toxicity | 12 months | Number of participants that experienced a Life-Threatening Toxicity (grade \>/= 4) as defined by Common toxicity Criteria (CTC) version 2.0. The CTC 2.0 is a set of criteria for the standardized classification of adverse effects. Adverse events are graded accordingly: 0 = No adverse event or within normal limits 1 = Mild adverse event 2 = Moderate adverse event 3 = Severe and undesirable adverse event 4 = Life-threatening or disabling adverse event 5 = Death related to adverse event |
| Secondary | Number of Participants That Are Relapse-free Survival Following Campath Infusion. | Month 12 | Number of participants that are Relapse-free survival following Campath infusion. Relapse is defined as a fall in peripheral blood counts to 50% the values obtained during the response period. |
| Secondary | Number of Participants With Molecular Response to Campath | Up to Month 12 | Number of Participants with Molecular Response to Campath. Molecular Response to Campath is defined as disappearance of the clonal population of T-LGL |
| Secondary | Participant Response at 6 Months | 6 months | Participant response at 6 months following Alemtuzumab. A complete response (CR) was defined as normalization of all affected lineages, and a partial response (PR) was defined in neutropenic subjects as 100% increase in the ANC to \>500/µL, and in those with anemia, any increase in hemoglobin of 2 g/dL or more observed in at least two serial measurements 1 week apart and sustained for one month or more without exogenous growth factors support or transfusions. |
| Secondary | Participants Response to a Second Cycle of Campath | 12 months | Participants Response to a second cycle of Campath. A complete response (CR) was defined as normalization of all affected lineages, and a partial response (PR) was defined in neutropenic subjects as 100% increase in the ANC to \>500/µL, and in those with anemia, any increase in hemoglobin of 2 g/dL or more observed in at least two serial measurements 1 week apart and sustained for one month or more without exogenous growth factors support or transfusions. |
| Secondary | Number of Participants With Clone Size Improvements | Up to 6 months | Number of participants with clone size improvements following Alu |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Hematological Response After Three Months of Alemtuzumab | 3 months | The analyses included only those subjects who were given Alemtuzumab. Analysis was by intention to treat. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants That Are Red Blood Cell and/or Platelet Transfusion-Independent | 3 months | Analysis was by intention to treat. One participant not evaluable, died prior to 3 months. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants Overall Survival After Alemtuzumab Infusion | 3 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants That Experienced a Life-Threatening Toxicity | 12 months | Analysis was by intention to treat. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants That Are Relapse-free Survival Following Campath Infusion. | Month 12 | 10 participants were not evaluable | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Molecular Response to Campath | Up to Month 12 | Participants who completed molecular testing | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participant Response at 6 Months | 6 months | 5 participants were not evaluable. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Participants Response to a Second Cycle of Campath | 12 months | Participants that received a second cycle of Campath | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clone Size Improvements | Up to 6 months | 3 participants were not evaluable as no data was collected. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Hematological Response After Three Months of Alemtuzumab | Alemtuzumab in Patients With T Cell Large Granular Lymphocytic Leukemia (T-LGL) | 15 | Participants | ||
| Number of Participants That Are Red Blood Cell and/or Platelet Transfusion-Independent | Alemtuzumab in Participants With T Cell Large Granular Lymphocytic Leukemia (T-LGL) | Both red blood cell and platelet transfusion-independent | 16 | Participants | |
| Number of Participants That Are Red Blood Cell and/or Platelet Transfusion-Independent | Alemtuzumab in Participants With T Cell Large Granular Lymphocytic Leukemia (T-LGL) | Either red blood cell or platelet transfusion-dependent | 12 | Participants | |
| Participants Overall Survival After Alemtuzumab Infusion | Alemtuzumab in Participants With T Cell Large Granular Lymphocytic Leukemia (T-LGL) | Alive | 28 | Participants | |
| Participants Overall Survival After Alemtuzumab Infusion | Alemtuzumab in Participants With T Cell Large Granular Lymphocytic Leukemia (T-LGL) | Deceased | 1 | Participants | |
| Number of Participants That Experienced a Life-Threatening Toxicity | Alemtuzumab in Patients With T Cell Large Granular Lymphocytic Leukemia (T-LGL) | Lymphocyte count decreased | 13 | Participants | |
| Number of Participants That Experienced a Life-Threatening Toxicity | Alemtuzumab in Patients With T Cell Large Granular Lymphocytic Leukemia (T-LGL) | White blood cell decreased | 3 | Participants | |
| Number of Participants That Experienced a Life-Threatening Toxicity | Alemtuzumab in Patients With T Cell Large Granular Lymphocytic Leukemia (T-LGL) | Platelet count decreased | 2 | Participants | |
| Number of Participants That Experienced a Life-Threatening Toxicity | Alemtuzumab in Patients With T Cell Large Granular Lymphocytic Leukemia (T-LGL) | Neutrophil count decreased | 1 | Participants | |
| Number of Participants That Experienced a Life-Threatening Toxicity | Alemtuzumab in Patients With T Cell Large Granular Lymphocytic Leukemia (T-LGL) | Monocytes count decreased | 1 | Participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Alemtuzumab in Patients With T Cell Large Granular Lymphocytic Leukemia (T-LGL) | 29 | |
| Overall Study | COMPLETED | Alemtuzumab in Patients With T Cell Large Granular Lymphocytic Leukemia (T-LGL) | 27 | |
| Overall Study | NOT COMPLETED | Alemtuzumab in Patients With T Cell Large Granular Lymphocytic Leukemia (T-LGL) | 2 |
Source ClinicalTrials.gov
Adverse events160
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Febrile neutropenia | Blood and lymphatic system disorders | Alemtuzumab in Patients With T Cell Large Granular Lymphocytic Leukemia (T-LGL) | 2 | 29 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Alemtuzumab in Patients With T Cell Large Granular Lymphocytic Leukemia (T-LGL) | 1 | 29 | |
| other | Petechiae | Blood and lymphatic system disorders | Alemtuzumab in Patients With T Cell Large Granular Lymphocytic Leukemia (T-LGL) | 1 | 29 | |
| other | Arrhythmia | Cardiac disorders | Alemtuzumab in Patients With T Cell Large Granular Lymphocytic Leukemia (T-LGL) | 1 | 29 | |
| other | Atrial fibrillation | Cardiac disorders | Alemtuzumab in Patients With T Cell Large Granular Lymphocytic Leukemia (T-LGL) | 1 | 29 | |
| other | Chest discomfort | Cardiac disorders | Alemtuzumab in Patients With T Cell Large Granular Lymphocytic Leukemia (T-LGL) | 1 | 29 | |
| other | Chest pain | Cardiac disorders | Alemtuzumab in Patients With T Cell Large Granular Lymphocytic Leukemia (T-LGL) | 2 | 29 | |
| other | Dizziness | Cardiac disorders | Alemtuzumab in Patients With T Cell Large Granular Lymphocytic Leukemia (T-LGL) | 5 | 29 | |
| other | Dizziness postural | Cardiac disorders | Alemtuzumab in Patients With T Cell Large Granular Lymphocytic Leukemia (T-LGL) | 1 | 29 | |
| other | Dyspnea | Cardiac disorders | Alemtuzumab in Patients With T Cell Large Granular Lymphocytic Leukemia (T-LGL) | 5 | 29 |
1 to 10 of 160Source ClinicalTrials.gov
See all 160 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Alemtuzumab in Patients With T Cell Large Granular Lymphocytic Leukemia (T-LGL) | 8 | 29 |
| Total, other adverse events | Alemtuzumab in Patients With T Cell Large Granular Lymphocytic Leukemia (T-LGL) | 29 | 29 |
| Total, serious adverse events | Alemtuzumab in Patients With T Cell Large Granular Lymphocytic Leukemia (T-LGL) | 13 | 29 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00345345
GET https://conductscience.org/api/trials/v1/NCT00345345/results?page=2